Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

July 31, 2006

Prewar Iraq Intelligence Report Delayed

Global Security Newswire

A congressional investigation into U.S. intelligence on prewar Iraq might not be completed until after November elections, the Washington Post reported yesterday (see GSN, June 30).

The Senate Select Committee on Intelligence has yet to complete the work, even though Chairman Pat Roberts (R-Kan.) said the document was nearly finished nine months ago. Committee sources, however, said work on the report largely began in November after Democrats protested the slow pace of the investigation. Two of its five sections are ready for a panel vote, according to staffers.

The delay in part is the result of Roberts’ desire to allow members to contribute, said spokeswoman Sarah Ross Little. She the two completed sections would be made public “when they are approved by the committee and have been declassified,” ahead of the other three still in progress.

The section Democrats are most concerned about examines the administration’s considerations of prewar intelligence, as well as officials’ public characterizations of that evidence. It is not yet in draft form and might not be released until after November elections, staffers said.

The first part of the committee’s report was issued in 2004, the Post reported. That investigation found that U.S. intelligence had overestimated prewar Iraq’s weapons arsenal. The second phase is now expected to focus on the White House use of intelligence and public statements about the threat.

Staff members said the portion of the inquiry on the Pentagon’s Special Plans Office, which stopped cooperating with the Senate panel last year, is on hold pending a separate investigation by the Defense Department’s inspector general (Dafna Linzer, Washington Post, July 30).

New U.S. Biodefense Center Raises Concerns

Global Security Newswire

A biodefense laboratory now under construction near Washington, D.C. is to be operated under high secrecy and could raise questions about U.S. adherence to the Biological Weapons Convention, the Washington Post reported yesterday (see GSN, June 26).

Research conducted at the new National Biodefense Analysis and Countermeasures Center at Fort Detrick, Md., could lead to thousands of saved lives during an act of bioterrorism. Work conducted there is to include simulating biological attacks involving pathogens such as anthrax or engineered microbes (see related GSN story, today).

The center would be classified as a highly restricted facility. Few federal sites, including nuclear laboratories, operate at such high levels of concealment. Some arms control experts said such secrecy has become typical of U.S. Homeland Security Department biodefense efforts.

Some of this research operates in what experts describe as a legal gray zone of the treaty restricting development, production or use of biological weapons. The Bush administration says its biodefense efforts fall squarely within treaty law.

“Where the research exposes vulnerability, I’ve got to protect that, for the public’s interest,” said Bernard Courtney, NBACC scientific director. “We don’t need to be showing perpetrators the holes in our defense.”

Extreme secrecy could have a negative impact, said Tara O’Toole, founder of the Center for Biosecurity at the University of Pittsburgh Medical Center.

“The philosophy and practice behind NBACC looks like much of the rest of the administration’s philosophy and practice: ‘Our intent is good, so we can do whatever we want,’” she said. “This approach will only lead to trouble.”

Critics understand the need for confidentiality, but are concerned that too much secrecy could increase the risk of bioterrorism. That could occur if the laboratory conducts experiments without adequate oversight, or if it promotes similar secret work by other nations.

A limited number of public documents have been released about the laboratory, which had not quelled the concerns of critics. A 2004 slide show indicated the site’s work would include producing and testing small amounts of weaponized microbes and possibly genetically engineered viruses and bacteria. It also listed “red team” exercises that replicate terrorist attacks.

The type of research to be conducted calls for an extra effort to be transparent about the government’s objectives, according to bioweapons experts.

“If we saw others doing this kind of research, we would view it as an infringement of the bioweapons treaty,” said Milton Leitenberg, a senior research scholar and weapons expert at the University of Maryland’s School of Public Policy. “You can’t go around the world yelling about Iranian and North Korean programs — about which we know very little — when we’ve got all this going on.”

The laboratory is expected to be the foremost U.S. biological research institution focused on “science-based threat assessment.” Preparing for worst-case scenarios is likely to require production of actual weapons, current and former NBACC personnel said.

“De facto, we are going to make biowarfare pathogens at NBACC in order to study them,” said Penrose Albright, former assistant homeland security secretary for science and technology.Construction began last month on the $128 million, 160,000-square-foot facility. The eight-story structure is to house two NBACC divisions: a forensic testing center that would aid in the identification of bioterrorism offenders, and a Biothreat Characterization Center which would allow researchers to predict what attacks might look like.

Homeland Security officials would not disclose the specific projects planned, but the slide show noted 16 priorities, including: “Characterize classical, emerging and genetically engineered pathogens for their (biological threat agent) potential”; “Assess the nature of nontraditional, novel and nonendemic induction of disease from potential BTA”; and “Expand aerosol-challenge testing capacity for nonhuman primates.”

The Bush administration said the facility’s research would honor the 1972 Biological Weapons Convention.

“All of the programs we do are defensive in nature,” said Maureen McCarthy, Homeland Security’s research and development director. “Our job is to ensure that the civilian population of the country is protected, and that we know what the threats are.”

Compliance with the treaty centers on intent and that making small amounts of biological warfare agents for research is allowed under certain interpretations.

“How can I go to the people of my country and say, ‘I can’t do this important research because some arms control advocate told me I can’t?’” Albright said.

Other experts in international law, however, said some experiments conducted within the facility could violate the treaty’s ban on developing, stockpiling, acquiring or retaining microbes “of types and in quantities that have no justification” for peaceful purposes.

“The main problem with the ‘defensive intent’ test is that it does not reflect what the treaty actually says,” said David Fidler, an Indiana University School of Law professor and expert on the bioweapons convention. The treaty does not distinguish between defensive and offensive efforts, he said (Joby Warrick, Washington Post, June 22).

Custom-Built Pathogens Raise Bioterror Fears

In the past five years, new technology has made it easier to genetically modify microbes and even create new ones from scratch. Some worry that the developments could lead to novel and more dangerous kinds of bioterror threats.

Eckard Wimmer knows of a shortcut terrorists could someday use to get their hands on the lethal viruses that cause Ebola and smallpox. He knows it exceptionally well, because he discovered it himself.

In 2002, the German-born molecular geneticist startled the scientific world by creating the first live, fully artificial virus in the lab. It was a variation of the bug that causes polio, yet different from any virus known to nature. And Wimmer built it from scratch.

The virus was made wholly from nonliving parts, using equipment and chemicals on hand in Wimmer's small laboratory at the State University of New York here on Long Island. The most crucial part, the genetic code, was picked up for free on the Internet. Hundreds of tiny bits of viral DNA were purchased online, with final assembly in the lab.

Wimmer intended to sound a warning, to show that science had crossed a threshold into an era in which genetically altered and made-from-scratch germ weapons were feasible. But in the four years since, other scientists have made advances faster than Wimmer imagined possible.

Government officials, and scientists such as Wimmer, are only beginning to grasp the implications.

"The future," he said, "has already come."

Five years ago, deadly anthrax attacks forced Americans to confront the suddenly real prospect of bioterrorism. Since then the Bush administration has poured billions of dollars into building a defensive wall of drugs, vaccines and special sensors that can detect dangerous pathogens. But already, technology is hurtling past it. While government scientists press their search for new drugs for old foes such as classic anthrax, a revolution in biology has ushered in an age of engineered microbes and novel ways to make them.

The new technology opens the door to new tools for defeating disease and saving lives. But today, in hundreds of labs worldwide, it is also possible to transform common intestinal microbes into killers. Or to make deadly strains even more lethal. Or to resurrect bygone killers, such the 1918 influenza. Or to manipulate a person's hormones by switching genes on or off. Or to craft cheap, efficient delivery systems that can infect large numbers of people.

"The biological weapons threat is multiplying and will do so regardless of the countermeasures we try to take," said Steven M. Block, a Stanford University biophysicist and former president of the Biophysical Society. "You can't stop it, any more than you can stop the progress of mankind. You just have to hope that your collective brainpower can muster more resources than your adversaries'."

The Bush administration has acknowledged the evolving threat, and last year it appointed a panel of scientists to begin a years-long study of the problem. It also is building a large and controversial lab in Frederick, where new bioterrorism threats can be studied and tested. But overall, specific responses have been few and slow.

The U.S. Centers for Disease Control and Prevention has declined so far to police the booming gene-synthesis industry, which churns out made-to-order DNA to sell to scientists. Oversight of controversial experiments remains voluntary and sporadic in many universities and private labs in the United States, and occurs even more rarely overseas.

Bioterrorism experts say traditional biodefense approaches, such as stockpiling antibiotics or locking up well-known strains such as the smallpox virus, remain important. But they are not enough.

"There's a name for fixed defenses that can easily be outflanked: They are called Maginot lines," said Roger Brent, a California molecular biologist and former biodefense adviser to the Defense Department, referring to the elaborate but short-sighted network of border fortifications built by France after World War I to prevent future invasions by Germany.

"By themselves," Brent said, "stockpiled defenses against specific threats will be no more effective to the defense of the United States than the Maginot line was to the defense of France in 1940."

How to Make a Virus

Wimmer's artificial virus looks and behaves like its natural cousin -- but with a far reduced ability to maim or kill -- and could be used to make a safer polio vaccine. But it was Wimmer's techniques, not his aims, that sparked controversy when news of his achievement hit the scientific journals.

As the creator of the world's first "de novo" virus -- a human virus, at that -- Wimmer came under attack from other scientists who said his experiment was a dangerous stunt. He was accused of giving ideas to terrorists, or, even worse, of inviting a backlash that could result in new laws restricting scientific freedom.

Wimmer counters that he didn't invent the technology that made his experiment possible. He only drew attention to it.

"To most scientists and lay people, the reality that viruses could be synthesized was surprising, if not shocking," he said. "We consider it imperative to inform society of this new reality, which bears far-reaching consequences."

One of the world's foremost experts on poliovirus, Wimmer has made de novo poliovirus six times since his groundbreaking experiment four years ago. Each time, the work is a little easier and faster.

New techniques developed by other scientists allow the creation of synthetic viruses in mere days, not weeks or months. Hardware unveiled last year by a Harvard genetics professor can churn out synthetic genes by the thousands, for a few pennies each.

But Wimmer continues to use methods available to any modestly funded university biology lab. He reckons that tens of thousands of scientists worldwide already are capable of doing what he does.

"Our paper was the starting point of the revolution," Wimmer said. "But eventually the process will become so automated even technicians can do it."

Wimmer's method starts with the virus's genetic blueprint, a code of instructions 7,441 characters long. Obtaining it is the easiest part: The entire code for poliovirus, and those for scores of other pathogens, is available for free on the Internet.

Armed with a printout of the code, Wimmer places an order with a U.S. company that manufactures custom-made snippets of DNA, called oglionucleotides. The DNA fragments arrive by mail in hundreds of tiny vials, enough to cover a lab table in one of Wimmer's three small research suites.

Using a kind of chemical epoxy, the scientist and his crew of graduate assistants begin the tedious task of fusing small snippets of DNA into larger fragments. Then they splice together the larger strands until the entire sequence is complete.

The final step is almost magical. The finished but lifeless DNA, placed in a broth of organic "juice" from mushed-up cells, begins making proteins. Spontaneously, it assembles the trappings of a working virus around itself.

While simple on paper, it is not a feat for amateurs, Wimmer said. There are additional steps to making effective bioweapons besides acquiring microbes. Like many scientists and a sizable number of biodefense experts, Wimmer believes traditional terrorist groups such as al-Qaeda will stick with easier methods, at least for now.

Yet al-Qaeda is known to have sought bioweapons and has recruited experts, including microbiologists. And for any skilled microbiologist trained in modern techniques, Wimmer acknowledged, synthetic viruses are well within reach and getting easier.

"This," he said, "is a wake-up call."

From Parlor Trick to Bio-Bricks

The global biotech revolution underway is more than mere genetic engineering. It is genetic engineering on hyperdrive. New scientific disciplines such as synthetic biology, practiced not only in the United States but also in new white-coat enclaves in China and Cuba, seek not to tweak biological systems but to reinvent them.

The holy grail of synthetic biologists is the reduction of all life processes into building blocks -- interchangeable bio-bricks that can be reassembled into new forms. The technology envisions new species of microbes built from the bottom up: "living machines from off-the-shelf chemicals" to suit the needs of science, said Jonathan Tucker, a bioweapons expert with the Washington-based Center for Non-Proliferation Studies.

"It is possible to engineer living organisms the way people now engineer electronic circuits," Tucker said. In the future, he said, these microbes could produce cheap drugs, detect toxic chemicals, break down pollutants, repair defective genes, destroy cancer cells and generate hydrogen for fuel.

In less than five years, synthetic biology has gone from a kind of scientific parlor trick, useful for such things as creating glow-in-the-dark fish, to a cutting-edge bioscience with enormous commercial potential, said Eileen Choffnes, an expert on microbial threats with the National Academies' Institute of Medicine. "Now the technology can be even done at the lab bench in high school," she said.

Along with synthetic biologists, a separate but equally ardent group is pursuing DNA shuffling, a kind of directed evolution that imbues microbes with new traits. Another faction seeks novel ways to deliver chemicals and medicines, using ultra-fine aerosols that penetrate deeply into the lungs or new forms of microencapsulated packaging that control how drugs are released in the body.

Still another group is discovering ways to manipulate the essential biological circuitry of humans, using chemicals or engineered microbes to shut down defective genes or regulate the production of hormones controlling such functions as metabolism and mood.

Some analysts have compared the flowering of biotechnology to the start of the nuclear age in the past century, but there are important differences. This time, the United States holds no monopoly over the emerging science, as it did in the early years of nuclear power. Racing to exploit each new discovery are dozens of countries, many of them in the developing world.

There's no binding treaty or international watchdog to safeguard against abuse. And the secrets of biology are available on the Internet for free, said Robert L. Erwin at a recent Washington symposium pondering the new technology. He is a geneticist and founder of the California biotech firm Large Scale Biology Corp.

In May, when 300 synthetic biologists gathered in California for the second national conference in the history of their new field, they found protesters waiting.

"Scientists creating new life forms cannot be allowed to act as judge and jury," Sue Mayer, a veterinary cell biologist and director of GeneWatch UK, said in a statement signed by 38 organizations.

Activists are not the only ones concerned about where new technology could lead. Numerous studies by normally staid panels of scientists and security experts have also warned about the consequences of abuse. An unclassified CIA study in 2003 titled "The Darker Bioweapons Future" warned of a potential for a "class of new, more virulent biological agents engineered to attack" specific targets. "The effects of some of these engineered biological agents could be worse than any disease known to man," the study said.

It is not just the potential for exotic diseases that is causing concern. Harmless bacteria can be modified to carry genetic instructions that, once inside the body, can alter basic functions, such as immunity or hormone production, three biodefense experts with the Defense Intelligence Agency said in an influential report titled "Biotechnology: Impact on Biological Warfare and Biodefense."

As far as is publicly known, no such weapons have ever been used, although Soviet bioweapons scientists experimented with genetically altered strains in the final years of the Cold War. Some experts doubt terrorists would go to such trouble when ordinary germs can achieve the same goals.

"The capability of terrorists to embark on this path in the near- to mid-term is judged to be low," Charles E. Allen, chief intelligence officer for the Department of Homeland Security, said in testimony May 4 before a panel of the House Committee on Homeland Security. "Just because the technology is available doesn't mean terrorists can or will use it."

A far more likely source, Allen said, is a "lone wolf": a scientist or biological hacker working alone or in a small group, driven by ideology or perhaps personal demons. Many experts believe the anthrax attacks of 2001 were the work of just such a loner.

"All it would take for advanced bioweapons development," Allen said, "is one skilled scientist and modest equipment -- an activity we are unlikely to detect in advance."

Genes for Sale

Throughout the Western world and even in developing countries such as India and Iran, dozens of companies have entered the booming business of commercial gene synthesis. Last fall, a British scientific journal, New Scientist, decided to contact some of these DNA-by-mail companies to show how easy it would be to obtain a potentially dangerous genetic sequence -- for example, DNA for a bacterial gene that produces deadly toxins.

Only five of the 12 firms that responded said they screened customers' orders for DNA sequences that might pose a terrorism threat. Four companies acknowledged doing no screening at all. Under current laws, the companies are not required to screen.

In the United States, the federal "Select Agent" rule restricts access to a few types of deadly bacteria, viruses and toxins. But, under the CDC's interpretation of the rule, there are few such controls on transfers of synthetic genes that can be turned into killers. Changes are being contemplated, but for now the gap is one example of technology's rapid advance leaving law and policy behind.

"It would be possible -- fully legal -- for a person to produce full-length 1918 influenza virus or Ebola virus genomes, along with kits containing detailed procedures and all other materials for reconstitution," said Richard H. Ebright, a biochemist and professor at Rutgers University. "It is also possible to advertise and to sell the product, in the United States or overseas."

While scientists tend to be deeply skeptical of government intrusion into their laboratories, many favor closer scrutiny over which kinds of genetic coding are being sold and to whom. Even DNA companies themselves are lobbying for better oversight.

Blue Heron Biotechnology, a major U.S. gene-synthesis company based in suburban Seattle, formally petitioned the federal government three years ago to expand the Select Agent rule to require companies to screen DNA purchases. The company began voluntarily screening after receiving suspicious requests from overseas, including one from a Saudi customer asking for genes belonging to a virus that causes a disease akin to smallpox.

"The request turned out to be legitimate, from a real scientist, but it made us ask ourselves: How can we make sure that some crazy person doesn't order something from us?" said John Mulligan, Blue Heron's founder and chief executive. "I used to think that such a thing was improbable, but then September 11 happened."

Some scientists also favor greater scrutiny -- or at least peer review -- of research that could lead to the accidental or deliberate release of genetically modified organisms.

In theory, such oversight is provided by volunteer boards known as institutional biosafety committees. Guidelines set by the National Institutes of Health call on federally funded schools and private labs to each appoint such a board. A 2004 National Academy of Sciences report recommended that the committees take on a larger role in policing research that could lead to more powerful biological weapons.

In reality, many of these boards appear to exist only on paper. In 2004, the nonprofit Sunshine Project surveyed 390 such committees, asking for copies of minutes or notes from any meetings convened to evaluate research projects. Only 15 institutions earned high marks for showing full compliance with NIH guidelines, said Edward Hammond, who directed the survey. Nearly 200 others who responded had poor or missing records or none at all, he said. Some committees had never met.

Stockpiles Aren't Enough

New techniques that unlock the secrets of microbial life may someday lead to the defeat of bioterrorism threats and cures for natural diseases, too. But today, the search for new drugs of all kinds remains agonizingly slow.

Five years after the Sept. 11 attacks, the federal government budgets nearly $8 billion annually -- an 18-fold increase since 2001 -- for the defense of civilians against biological attack. Billions have been spent to develop and stockpile new drugs, most of them each tied to a single, well-known bioterrorism threat, such as anthrax.

Despite efforts to streamline the system, developing one new drug could still take up to a decade and cost hundreds of millions of dollars. If successful, the drug is a solution for just one disease threat out of a list that is rapidly expanding to include man-made varieties.

In a biological attack, waiting even a few weeks for new drugs may be disastrous, said Tara O'Toole, a physician and director of the Center for Biosecurity at the University of Pittsburgh Medical Center.

"We haven't yet absorbed the magnitude of this threat to national security," said O'Toole, who worries that the national commitment to biodefense is waning over time and the rise of natural threats such as pandemic flu. "It is true that pandemic flu is important, and we're not doing nearly enough, but I don't think pandemic flu could take down the United States of America. A campaign of moderate biological attacks could."

A Booster Shot for Pandemic Preparedness - Op-Ed - Bioport Lobbyist

WASHINGTON // The threat of bioterrorism, along with the global spread of infectious diseases such as avian flu and SARS, has put a spotlight on the critical need to improve America's fragile public health system. Outstanding progress has been made during the last year in biodefense and pandemic planning, but the United States needs to be ready for any significant worldwide threat. More preparation is still necessary.

In biodefense, the Department of Health and Human Services has acquired 10 million doses of safe, FDA-licensed anthrax vaccine to better prepare for another attack like the one in October 2001. HHS has also announced the long-awaited purchase of anthrax therapeutics for post-exposure treatment, as well as treatments for botulism poisoning. All of the purchases were made under the landmark Project BioShield Act of 2004, first proposed by President Bush in his 2003 State of the Union address as an effort to leverage the capital markets and the innovation of the biotechnology industry to secure the nation.

In research and development for pandemic vaccines, more than $1 billion in advance development contracts for next-generation, cell-culture influenza vaccines has been awarded to five companies pursuing multiple technologies. Given the recent challenges HHS has faced in delivering experimental anthrax vaccine from an unproven supplier, it is clear that the agency has learned not put all its eggs in one basket.

Perhaps most important, Mr. Bush in December signed the Public Readiness and Emergency Preparedness Act into law. The PREP Act greatly improves the country's ability to prepare for naturally occurring or terrorist-related public health emergencies by offering targeted liability protection to those involved in the development, manufacture and deployment of pandemic and epidemic products and security countermeasures. Vaccine and countermeasure developers are now better protected from the mass of lawsuits that have eviscerated the U.S. vaccine and biodefense manufacturing base, leaving it ill prepared for threats such as avian influenza.

Sen. Richard M. Burr, Republican of North Carolina, has also introduced new legislation creating the Biopharmaceutical Advanced Development Research Agency to further stimulate advance development of needed countermeasures for both bioterrorism and emerging infectious disease. Coupled with the president's commitment to fund the effort with nearly $200 million in his fiscal year 2007 budget, this is a positive development.

While bioterrorism remains a significant threat, pandemic preparedness, while foremost an issue of public health, is also an issue of business continuity, ensuring American global competitiveness. It has been estimated that only 7 percent of U.S. companies have established budgets for pandemic preparedness/business continuity, compared with 12 percent of European companies and 25 percent of Asian businesses.

Congress should act now to provide additional incentives, such as expanded liability protection to businesses that make reasonable and prudent efforts to prepare for a pandemic. Companies must plan for the contingency that 40 percent or more of their employees might not be able to come to work during a pandemic.

Any proper response will also require major supply-chain automation among pharmaceutical and medical supply companies, health care providers, and security organizations because significant numbers of workers may be sick or afraid to leave their homes. Congress should work now to ensure information technology provides protection from counterfeiting and theft of vaccine supplies, and should develop effective tracking mechanisms to safeguard the data needed for the supply chain to function.

Congress must act now to bolster our fragile public health infrastructure, in particular the country's hospital system. Should a pandemic strike, the surge on hospitals from both the sick and the merely worried has the potential to cripple our health care system. Painfully difficult triage decisions would be certain to generate a flood of liability litigation. The last thing the nation will need is baseless lawsuits, so Congress should work to protect the health care industry from pandemic-induced tort claims.

The U.S. also has a rare opportunity to fortify its public health infrastructure to support improved access to an influenza vaccine and better immunization for annual influenza, which kills more than 30,000 Americans each year. If we are better prepared to deal with the annual flu, we will be far better off should a pandemic strike.

Even if a devastating pandemic never happens or a bioterrorist attack never materializes, all of the preparation we undertake will not be lost if it helps to vastly improve the nation's emergency response infrastructure. If pandemic preparedness upgrades our public health and corporate supply chain, it will be well worth the effort.

John M. Clerici is a partner in a Washington law firm who specializes in homeland security policy. This article is adapted from his recent testimony before the Senate Appropriations Committee's Subcommittee on Homeland Security. His e-mail is jclerici@mckennalong.com.

The column "A booster shot for pandemic preparedness" (Opinion Commentary, July 31) referred to my company as an "unproven supplier" of an "experimental anthrax vaccine" and stated that the Department of Health and Human Services has apparently learned not to "put all its eggs in one basket." Readers should take what was presented in the column with appropriate caution.

Its author, John Clerici, was identified as a partner in a Washington law firm. But the column failed to disclose that Mr. Clerici is a key lobbyist for Emergent Biosolutions (formerly known as BioPort), the maker of a decades-old anthrax vaccine with a potential side-effect profile that has caused persistent concern among servicemen and women.

And these are the facts about how our contract was awarded: Multiple expert reviews concluded that the existing, licensed vaccine produced by Emergent Biosolutions was inadequate. The government then determined that VaxGen was the best-qualified supplier to develop, manufacture and deliver 75 million doses of a next-generation anthrax vaccine for the country's strategic national stockpile.

The government not only considered other companies but weighed VaxGen's performance under two previous anthrax vaccine development contracts.

Piers Whitehead Brisbane, Calif. The writer is a vice president of VaxGen Inc.

US begins building treaty-breaching germ war defence centre

Construction work has begun near Washington on a vast germ warfare laboratory intended to help protect the US against an attack with biological weapon, but critics say the laboratory's work will violate international law and its extreme secrecy will exacerbate a biological arms race.

The National Biodefence Analysis and Countermeasures Centre (NBACC), due to be completed in 2008, will house heavily guarded and hermetically sealed chambers in which scientists simulate potential terrorist attacks.

To do so, the centre will have to produce and stockpile the world's most lethal bacteria and viruses, which is forbidden by the 1972 Biological and Toxin Weapons Convention.

Three years before that treaty was agreed, President Richard Nixon halted the production of US biological weapons at Fort Detrick in Maryland. The same military base is the site for the new $128m (£70m), 160,000 sq ft laboratory.

The green light for its construction was given after the September 11 attacks, which coincided with a series of still-unsolved anthrax incidents that killed five people. The department of homeland security, which will run the centre, says its work is necessary to protect the country.

"All the programmes we do are defensive in nature," Maureen McCarthy, director of homeland security research and development, told the Washington Post. "Our job is to ensure that the civilian population of the country is protected, and that we know what the threats are."

The biological weapons convention stipulates that the signatories must not "develop, produce, stockpile, or otherwise acquire or retain" biological weapons, and does not distinguish between offensive and defensive intentions.

A presentation given by Lieutenant Colonel George Korch said the NBACC would be used to apply "red team operational scenarios and capabilities" - military jargon for simulating enemy attacks.

Some analysts say the extraordinary secrecy surrounding the project will heighten suspicions of US intentions and accelerate work on similar facilities around the world.

A Booster Shot for Pandemic Preparedness

By John M. Clerici

WASHINGTON // The threat of bioterrorism, along with the global spread of infectious diseases such as avian flu and SARS, has put a spotlight on the critical need to improve America's fragile public health system. Outstanding progress has been made during the last year in biodefense and pandemic planning, but the United States needs to be ready for any significant worldwide threat. More preparation is still necessary.

In biodefense, the Department of Health and Human Services has acquired 10 million doses of safe, FDA-licensed anthrax vaccine to better prepare for another attack like the one in October 2001. HHS has also announced the long-awaited purchase of anthrax therapeutics for post-exposure treatment, as well as treatments for botulism poisoning. All of the purchases were made under the landmark Project BioShield Act of 2004, first proposed by President Bush in his 2003 State of the Union address as an effort to leverage the capital markets and the innovation of the biotechnology industry to secure the nation.

In research and development for pandemic vaccines, more than $1 billion in advance development contracts for next-generation, cell-culture influenza vaccines has been awarded to five companies pursuing multiple technologies. Given the recent challenges HHS has faced in delivering experimental anthrax vaccine from an unproven supplier, it is clear that the agency has learned not put all its eggs in one basket.

Perhaps most important, Mr. Bush in December signed the Public Readiness and Emergency Preparedness Act into law. The PREP Act greatly improves the country's ability to prepare for naturally occurring or terrorist-related public health emergencies by offering targeted liability protection to those involved in the development, manufacture and deployment of pandemic and epidemic products and security countermeasures. Vaccine and countermeasure developers are now better protected from the mass of lawsuits that have eviscerated the U.S. vaccine and biodefense manufacturing base, leaving it ill prepared for threats such as avian influenza.

Sen. Richard M. Burr, Republican of North Carolina, has also introduced new legislation creating the Biopharmaceutical Advanced Development Research Agency to further stimulate advance development of needed countermeasures for both bioterrorism and emerging infectious disease. Coupled with the president's commitment to fund the effort with nearly $200 million in his fiscal year 2007 budget, this is a positive development.

While bioterrorism remains a significant threat, pandemic preparedness, while foremost an issue of public health, is also an issue of business continuity, ensuring American global competitiveness. It has been estimated that only 7 percent of U.S. companies have established budgets for pandemic preparedness/business continuity, compared with 12 percent of European companies and 25 percent of Asian businesses.

Congress should act now to provide additional incentives, such as expanded liability protection to businesses that make reasonable and prudent efforts to prepare for a pandemic. Companies must plan for the contingency that 40 percent or more of their employees might not be able to come to work during a pandemic.

Any proper response will also require major supply-chain automation among pharmaceutical and medical supply companies, health care providers, and security organizations because significant numbers of workers may be sick or afraid to leave their homes. Congress should work now to ensure information technology provides protection from counterfeiting and theft of vaccine supplies, and should develop effective tracking mechanisms to safeguard the data needed for the supply chain to function.

Congress must act now to bolster our fragile public health infrastructure, in particular the country's hospital system. Should a pandemic strike, the surge on hospitals from both the sick and the merely worried has the potential to cripple our health care system. Painfully difficult triage decisions would be certain to generate a flood of liability litigation. The last thing the nation will need is baseless lawsuits, so Congress should work to protect the health care industry from pandemic-induced tort claims.

The U.S. also has a rare opportunity to fortify its public health infrastructure to support improved access to an influenza vaccine and better immunization for annual influenza, which kills more than 30,000 Americans each year. If we are better prepared to deal with the annual flu, we will be far better off should a pandemic strike.

Even if a devastating pandemic never happens or a bioterrorist attack never materializes, all of the preparation we undertake will not be lost if it helps to vastly improve the nation's emergency response infrastructure. If pandemic preparedness upgrades our public health and corporate supply chain, it will be well worth the effort.

John M. Clerici is a partner in a Washington law firm who specializes in homeland security policy. This article is adapted from his recent testimony before the Senate Appropriations Committee's Subcommittee on Homeland Security. His e-mail is jclerici@mckennalong.com.

Cangene Gets $143M HHS Contract for Anthrax Drug

BioWorld Today

Two months after getting a $362 million contract for its botulism treatment under the U.S. government's Project BioShield, Canadian firm Cangene Corp. has added a separate deal, valued at $143.8 million, for its anthrax product.

The Department of Health and Human Services exercised its option from a September 2005 agreement to purchase, over a three-year period, 10,000 doses of Cangene's anthrax immune globulin (AIG). That decision followed the completion of successful preliminary efficacy testing of the drug.

AIG, an antibody derived from donors immunized with the anthrax vaccine, is a hyperimmune product designed to treat inhalation anthrax, an acute infectious disease caused by inhaling spores of Bacillus anthracis.

AIG is the second anthrax drug to win a U.S. contract this summer. Last month, Human Genome Sciences Inc., of Rockville, Md., was awarded a deal worth $165 million to contribute 20,000 doses of its monoclonal antibody ABthrax. (See BioWorld Today, June 21, 2006.)

According to the HHS, Cangene is expected to begin delivering AIG to the Strategic National Stockpile beginning in 2007, though full payment of the contract is contingent upon the product gaining FDA approval. Prior to marketing clearance, the drug will be available only for emergency use.

Cangene will manufacture AIG at its Winnipeg, Manitoba, facility, the same one responsible for producing its botulism drug, botulinum toxin immune globulin (heptavalent botulism antitoxin). On May 31, the company reported a five-year, $362 million contract with HHS to supply 200,000 doses of the product, which is designed to treat exposure to the bacteria and/or the toxin that causes botulism. (See BioWorld Today, June 2, 2006.)

In addition to hyperimmune products, Winnipeg-based Cangene also develops biopharmaceuticals. Most recently, the company filed a new drug application for Accretropin, a recombinant human growth hormone product aimed at treating children with growth hormone deficiency and girls with Turner Syndrome.

Cangene reported net income of C$4.8 million (US$4.2 million), or C7 cents per share, for its third quarter ending April 30. As of that date, the company had cash and accounts receivables totaling C$34.2 million.

Shares of Cangene (TSX:CNJ) gained C40 cents Friday, to close at C$8.30.

July 30, 2006

The Secretive Fight Against Bioterror

By Joby WarrickWashington Post Staff Writer

The government is building a highly classified facility to research biological weapons, but its closed-door approach has raised concerns.

On the grounds of a military base an hour's drive from the capital, the Bush administration is building a massive biodefense laboratory unlike any seen since biological weapons were banned 34 years ago.

The heart of the lab is a cluster of sealed chambers built to contain the world's deadliest bacteria and viruses. There, scientists will spend their days simulating the unthinkable: bioterrorism attacks in the form of lethal anthrax spores rendered as wispy powders that can drift for miles on a summer breeze, or common viruses turned into deadly superbugs that ordinary drugs and vaccines cannot stop.

The work at this new lab, at Fort Detrick, Md., could someday save thousands of lives -- or, some fear, create new risks and place the United States in violation of international treaties. In either case, much of what transpires at the National Biodefense Analysis and Countermeasures Center (NBACC) may never be publicly known, because the Bush administration intends to operate the facility largely in secret.

In an unusual arrangement, the building itself will be classified as highly restricted space, from the reception desk to the lab benches to the cages where animals are kept. Few federal facilities, including nuclear labs, operate with such stealth. It is this opacity that some arms-control experts say has become a defining characteristic of U.S. biodefense policy as carried out by the Department of Homeland Security, NBACC's creator.

Since the department's founding in the aftermath of the Sept. 11 attacks, its officials have dramatically expanded the government's ability to conduct realistic tests of the pathogens and tactics that might be used in a bioterrorism attack. Some of the research falls within what many arms-control experts say is a legal gray zone, skirting the edges of an international treaty outlawing the production of even small amounts of biological weapons.

The administration dismisses these concerns, however, insisting that the work of NBACC is purely defensive and thus fully legal. It has rejected calls for oversight by independent observers outside the department's network of government scientists and contractors. And it defends the secrecy as necessary to protect Americans.

"Where the research exposes vulnerability, I've got to protect that, for the public's interest," said Bernard Courtney, NBACC's scientific director. "We don't need to be showing perpetrators the holes in our defense."

Tara O'Toole, founder of the Center for Biosecurity at the University of Pittsburgh Medical Center and an adviser to the Defense Department on bioterrorism, said the secrecy fits a larger pattern and could have consequences. "The philosophy and practice behind NBACC looks like much of the rest of the administration's philosophy and practice: 'Our intent is good, so we can do whatever we want,' " O'Toole said. "This approach will only lead to trouble."

Although they acknowledge the need to shield the results of some sensitive projects from public view, critics of NBACC fear that excessive secrecy could actually increase the risk of bioterrorism. That would happen, they say, if the lab fosters ill-designed experiments conducted without proper scrutiny or if its work fuels suspicions that could lead other countries to pursue secret biological research.

The few public documents that describe NBACC's research mission have done little to quiet those fears. A computer slide show prepared by the center's directors in 2004 offers a to-do list that suggests the lab will be making and testing small amounts of weaponized microbes and, perhaps, genetically engineered viruses and bacteria. It also calls for "red team" exercises that simulate attacks by hostile groups.

NBACC's close ties to the U.S. intelligence community have also caused concern among the agency's critics. The CIA has assigned advisers to the lab, including at least one member of the "Z-Division," an elite group jointly operated with Lawrence Livermore National Laboratory that specializes in analyzing and duplicating weapons systems of potential adversaries, officials familiar with the program confirm.

Bioweapons experts say the nature of the research envisioned for NBACC demands an unusually high degree of transparency to reassure Americans and the rest of the world of the U.S. government's intentions.

"If we saw others doing this kind of research, we would view it as an infringement of the bioweapons treaty," said Milton Leitenberg, a senior research scholar and weapons expert at the University of Maryland's School of Public Policy. "You can't go around the world yelling about Iranian and North Korean programs -- about which we know very little -- when we've got all this going on."

Creating the Weapons of Terrorism

Created without public fanfare a few months after the 2001 anthrax attacks, NBACC is intended to be the chief U.S. biological research institution engaged in something called "science-based threat assessment." It seeks to quantitatively answer one of the most difficult questions in biodefense: What's the worst that can happen?

To truly answer that question, there is little choice, current and former NBACC officials say: Researchers have to make real biological weapons.

"De facto, we are going to make biowarfare pathogens at NBACC in order to study them," said Penrose "Parney" Albright, former Homeland Security assistant secretary for science and technology.

Other government agencies, such as the Centers for Disease Control and Prevention, study disease threats such as smallpox to discover cures. By contrast, NBACC (pronounced EN-back) attempts to get inside the head of a bioterrorist. It considers the wide array of potential weapons available. It looks for the holes in society's defenses where an attacker might achieve the maximum harm. It explores the risks posed by emerging technologies, such as new DNA synthesizing techniques that allow the creation of genetically altered or man-made viruses. And it tries in some cases to test the weapon or delivery device that terrorists might use.

Research at NBACC is already underway, in lab space that has been outsourced or borrowed from the Army's sprawling biodefense campus at Fort Detrick in Frederick. It was at this compound that the U.S. government researched and produced offensive biological weapons from the 1940s until President Richard M. Nixon halted research in 1969. The Army continues to conduct research on pathogens there.

In June, construction began on a $128 million, 160,000-square-foot facility inside the same heavily guarded compound. Space inside the eight-story, glass-and-brick structure will be divided between NBACC's two major divisions: a forensic testing center tasked with using modern sleuthing techniques to identify the possible culprits in future biological attacks; and the Biothreat Characterization Center, or BTCC, which seeks to predict what such attacks will look like.

It is the BTCC's wing that will host the airtight, ultra-secure containment labs where the most controversial research will be done. Homeland Security officials won't talk about specific projects planned or underway. But the 2004 computer slide show -- posted briefly on a Homeland Security Web site before its discovery by agency critics prompted an abrupt removal -- offers insight into NBACC's priorities.

The presentation by NBACC's then-deputy director, Lt. Col. George Korch, listed 16 research priorities for the new lab. Among them:

"Assess the nature of nontraditional, novel and nonendemic induction of disease from potential BTA.

"Expand aerosol-challenge testing capacity for non-human primates.

"Apply Red Team operational scenarios and capabilities."

Courtney, the NBACC science director, acknowledged that his work would include simulating real biological threats -- but not just any threats.

"If I hear a noise on the back porch, will I turn on the light to decide whether there's something there, or go on my merry way?" Courtney asked. "But I'm only going to do [research] if I have credible information that shows it truly is a threat. It's not going to be dreamed up out of the mind of a novelist."

Administration officials note that there is a tradition for this kind of biological risk assessment, one that extends at least to the Clinton administration. In the late 1990s, for example, a clandestine project run by the Defense Department re-created a genetically modified, drug-resistant strain of the anthrax bacteria believed to have been made by Soviet bioweaponeers. Such research helped the government anticipate and prepare for emerging threats, according to officials familiar with the anthrax study.

Some arms-control experts see the comparison as troubling. They argued, then and now, that the work was a possible breach of a U.S.-negotiated international law.

Legal and Other Pitfalls

The Bush administration argues that its biodefense research complies with the Biological and Toxin Weapons Convention, the 1972 treaty outlawing the manufacture of biological weapons, because U.S. motives are pure.

"All the programs we do are defensive in nature," said Maureen McCarthy, Homeland Security's director of research and development, who oversees NBACC. "Our job is to ensure that the civilian population of the country is protected, and that we know what the threats are."

Current and former administration officials say that compliance with the treaty hinges on intent, and that making small amounts of biowarfare pathogens for study is permitted under a broad interpretation of the treaty. Some also argue that the need for a strong biodefense in an age of genetic engineering trumps concerns over what they see as legal hair-splitting.

"How can I go to the people of this country and say, 'I can't do this important research because some arms-control advocate told me I can't'?" asked Albright, the former Homeland Security assistant secretary.

But some experts in international law believe that certain experiments envisioned for the lab could violate the treaty's ban on developing, stockpiling, acquiring or retaining microbes "of types and in quantities that have no justification" for peaceful purposes.

"The main problem with the 'defensive intent' test is that it does not reflect what the treaty actually says," said David Fidler, an Indiana University School of Law professor and expert on the bioweapons convention. The treaty, largely a U.S. creation, does not make a distinction between defensive and offensive activities, Fidler said.

More practically, arms experts say, future U.S. governments may find it harder to object if other countries test genetically engineered pathogens and novel delivery systems, invoking the same need for biodefense.

Already, they say, there is evidence abroad of what some are calling a "global biodefense boom." In the past five years, numerous governments, including some in the developing world -- India, China and Cuba among them -- have begun building high-security labs for studying the most lethal bacteria and viruses.

"These labs have become a status symbol, a prestige item," said Alan Pearson, a biologist at the Center for Arms Control and Non-Proliferation. "A big question is: Will these labs have transparency?"

Secrecy May Have a Price

When it opens in two years, the NBACC lab will house an impressive collection of deadly germs and teams of scientists in full-body "spacesuits" to work with them. It will also have large aerosol-test chambers where animals will be exposed to deadly microbes. But the lab's most controversial feature may be its secrecy.

Homeland Security officials disclosed plans to contractors and other government agencies to classify the entire lab as a Sensitive Compartmented Information Facility, or SCIF.

In common practice, a SCIF (pronounced "skiff") is a secure room where highly sensitive information is stored and discussed. Access to SCIFs is severely limited, and all of the activity and conversation inside is presumed to be restricted from public disclosure. There are SCIFs in the U.S. Capitol, where members of Congress are briefed on military secrets. In U.S. nuclear labs, computers that store weapons data are housed inside SCIFs.

Homeland Security officials plan to operate all 160,000 square feet of NBACC as a SCIF. Because of the building's physical security features -- intended to prevent the accidental release of dangerous pathogens -- it was logical to operate it as a SCIF, McCarthy said.

"We need to protect information at a level that is appropriate," McCarthy added, saying she expects much of the lab's less-sensitive work to be made public eventually.

But some biodefense experts, including some from past administrations, viewed the decision as a mistake.

"To overlay NBACC with a default level of high secrecy seems like overkill," said Gerald L. Epstein, a former science adviser to the White House's National Security Council and now a senior fellow with the Center for Strategic and International Studies. While accepting that some secrecy is needed, he said the NBACC plan "sends a message that is not at all helpful."

NBACC officials also have resisted calls for the kind of broad, independent oversight that many experts say is necessary to assure other countries and the American public about their research.

Homeland Security spokesmen insist that NBACC's work will be carefully monitored, but on the department's terms.

"We have our own processes to scrutinize our research, and it includes compliance to the bioweapons convention guidelines as well as scientific oversight," said Courtney, the NBACC scientific director.

In addition to the department's internal review boards, the agency will bring in small groups of "three or four scientists" on an ad-hoc basis to review certain kinds of potentially controversial experiments, Courtney said. The review panels will be "independent," Courtney said, but he noted that only scientists with government security clearances will be allowed to participate.

Some experts have called for unusual forms of oversight, including panels of well-respected, internationally known scientists and observers from overseas. While allowing that the results of some experiments should be kept confidential, O'Toole, of the Center for Biosecurity, argues that virtually everything else at NBACC should be publicly accountable if the United States is to be a credible leader in preventing the proliferation of bioweapons.

"We're going to have to lean over backward," O'Toole said. "We have no leverage among other nation-states if we say, 'We can do whatever we want, but you can't. We want to see your biodefense program, but you can't see ours.' "

In recent weeks, NBACC's first officially completed project has drawn criticism, not because of its methods or procedures, but because heavy classification has limited its usefulness.

The project was an ambitious attempt to assess and rank the threats posed by dozens of different pathogens and delivery systems, drawing on hundreds of studies and extensive computer modeling. When delivered to the White House in January, it was the most extensive survey of its kind, and one that could guide the federal government in making decisions about biodefense spending.

Six months later, no one outside a small group of officials and advisers with top security clearances has seen the results.

"Something this important shouldn't be secret," said Thomas V. Inglesby, an expert at the Center for Biosecurity who serves on a government advisory board that was briefed on the results. "How can we make policy decisions about matters of this scale if we're operating in the dark?"

A spy among us?

A Soviet mole might have smuggled deadly viruses out of a Maryland army base in the 1980's, experts says.

It could be the plot of a Cold War thriller: A Soviet mole burrows into America's top biodefense lab and steals strains of the deadly viruses that cause Rift Valley and Lassa fevers.

He ships the killer microbes back to Moscow in the bags of Aeroflot pilots, who turn them over to a super-secret arm of the KGB that plots bioterror attacks.

A chilling tale of fictional intrigue? Some biowarfare experts think it actually happened at Fort Detrick in the 1980s, and they say there is evidence to support their suspicions.

Alexander Y. Kouzminov, a biophysicist who says he once worked for the KGB, first made the allegation last year in a book, Biological Espionage: Special Operations of the Soviet and Russian Foreign Intelligence Services in the West.

Biowarfare experts dismissed the memoir at first, largely because Kouzminov also claimed that a series of contemporary disease outbreaks resulted from the release of germ weapons.

But in recent weeks, another former Soviet scientist told The Sun that his lab routinely received dangerous pathogens and other materials from Western labs through a clandestine channel like the one Kouzminov described.

Also, a U.S. arms control specialist says he has independent evidence of a Soviet spy at Fort Detrick. Although not definitive, their statements buttress Kouzminov's allegations about the Frederick military installation.

Experts worry that the United States' huge $7-billion-a-year biological defense effort will increase the odds of bioterrorism - by generating dangerous new microbes and scientific knowledge that could be diverted or stolen.

The FBI declined to comment on the possibility of Soviet spying at Fort Detrick in the 1980s. However, if an agent once penetrated America's top biodefense lab, biowarfare experts say, the incident would show how difficult preventing such losses can be.

The Detrick agent, Kouzminov wrote, clandestinely "gained information" on experiments with Rift Valley and Lassa fevers, hemorrhagic diseases that can drown a victim in his own body fluid, as well as the bacterium that causes tularemia, which can cause diarrhea, vomiting and pneumonia.

KGB officials also sought a sample of the U.S. smallpox vaccine, although Kouzminov does not say whether they obtained it. Soviet defectors have reported that in the 1970s and 1980s, the U.S.S.R. was trying to develop vaccine-resistant organisms capable of defeating U.S. biowarfare defenses.

Serguei Popov, a scientist once based in a Soviet bioweapons lab in Obolensk, south of Moscow, said that by the early 1980s his colleagues had obtained at least two strains of anthrax commonly studied in Detrick and affiliated labs. They included the Ames strain, first identified at Detrick in the early 1980s. It became the standard used for testing U.S. military vaccines, and it was the strain contained in the 2001 anthrax letters that killed five people and infected 23 in the U.S.

Popov, now at the National Center for Biodefense and Infectious Disease at George Mason University in Fairfax, Va., said Obolensk researchers could easily obtain organisms mentioned in Western research papers.

"If you wanted 'special materials,' you had to fill out a request," he said. "And, essentially, those materials were provided. How and by whom, I can't say."

One colleague, Popov said, used this "special materials" program to obtain a strain of Yersinia pestis, a plague bacterium being studied in a Western lab. But he didn't know whether that particular germ came from Detrick.

There has never been any doubt about Detrick's key role in the history of U.S. biowarfare. Once a sleepy military airfield, the facility was turned into a center for top-secret research into biological weapons in the waning days of World War II.

It remained so until 1969, when President Richard M. Nixon ended development of new U.S. bioweapons, and the military study of lethal organisms shifted to the U.S. Army Medical Research Institute of Infectious Diseases, or USAMRIID.

That agency was founded at Fort Detrick in the late 1960s to conduct defensive biological research. Its scientists developed new vaccines and drugs to treat natural and manmade outbreaks.

Given that change in mission, former Detrick scientists and arms control experts agree that there were no secret, offensive programs at Detrick in the 1980s. In fact, they say there wasn't much secret work at all.

But Kouzminov says the KGB still wanted specific items from Western labs - including Detrick - that were closely held or at least not widely available.

Those included samples of specific disease strains, the growth media used to raise microbes, and vaccines the labs developed. The Soviets also wanted the aerosol powders U.S. scientists used to infect animals with bioagents during drug and vaccine tests.

At least three KGB spies targeted U.S. biodefense efforts in the 1980s, Kouzminov said. But the biophysicist, who worked primarily in Western Europe, offers no details about what the other two did. He wrote that his superiors called "our man at Detrick" their key biological agent.

Kouzminov and the biological moles worked in the KGB's Department 12 of Directorate S, housed in a high-rise building in a forested patch of southern Moscow. The group's mission, he said, was to develop germ weapons and poisons, to steal biodefense secrets and to plot biochemical terror attacks to be launched in the event of war.

The description of Department 12 in Biological Espionage squares with those of other defectors, said Oleg D. Kalugin, a retired KGB major general now living in the U.S.

Raymond Zilinskas, a bioweapons expert with the Monterey Institute of International Studies, and two colleagues wrote a scathing review of Biological Espionage in Nature, a British scientific journal.

The authors challenged Kouzminov's claims that the U.S. is pursuing an offensive bioweapons program. For example, he suggested that the 1993 outbreak of hantavirus in the American Southwest resulted from a U.S. military release of a bioweapon genetically engineered to attack Native Americans. The Nature review called the allegation "bizarre" and "astonishing."

The authors also complained that Kouzminov revealed few real KGB secrets. "It seems surprising," the reviewers wrote, "that an insider can write a book about the special operations of Soviet foreign intelligence services ... and provide so little about their achievements."

But Zilinskas, who is researching a history of the Soviet bioweapons program, told The Sun this month that his sources now say that Soviet intelligence routinely obtained details of work at USAMRIID that went beyond the descriptions in scientific journals.

"It was clear there was somebody at Fort Detrick" who worked for Soviet intelligence, Zilinskas says.

According to Kouzminov's account, the KGB delivered biological materials to Moscow through what was called the VOLNA channel. Aeroflot pilots who were also KGB officers carried these sometimes-lethal microbes to Moscow's Sheremetyevo airport in their personal luggage.

By the late 1980s, Department 12 was receiving about 20 parcels a year through VOLNA from agents in its American section, which included North, Central and South America.

In an e-mail, Kouzminov said he didn't know the identity of the Detrick spy or other details of the USAMRIID espionage. Such knowledge was closely guarded, even within the KGB. Careless comments by his bosses, though, suggested that the agent was a devout Catholic whose work frequently took him to Latin America.

Milton Leitenberg, an arms control expert with the Center for International and Security Studies at the University of Maryland, College Park, investigated the spying claim last year. As far as he can determine, no one fitting Kouzminov's description worked at Detrick in the 1980s.

An FBI spokesman said the agency would not comment on spying allegations.

But William C. Patrick III, a retired Detrick biologist and veteran bioweapons expert, said he has long suspected penetration by Soviet agents.

His suspicions cropped up in the early 1990s, when he debriefed Ken Alibek, who as Kanatjan Alibekov served as the deputy chief of Biopreparat, the leading Soviet bioweapons research agency. Alibek emigrated to the U.S. less than a year after the dissolution of the Soviet Union in December 1991.

As he and Alibek traded stories, Patrick said, both realized that the Soviet and American programs had moved in a curious lock step during the 1950s and '60s.

"Anything we discovered of any import, they would have discovered and would have in their program in six months," Patrick said.

He doesn't doubt that the Soviets kept spying beyond the end of the U.S. offensive program. After his conversations with Alibek, he recalled, "For the next two weeks I tried to think, 'Who the hell are the spies at Detrick?'"

It would have been surprising if the KGB had not kept an eye on Fort Detrick, which was vilified in the Soviet press as a palace of sinister secrets.

Researchers who worked at Detrick at the time say there was no basis for this notoriety. Dr. C. J. Peters, a researcher and administrator at USAMRIID from 1977 to 1992, said a mole at Detrick in those days wouldn't have turned up critical intelligence - or obtained germs - that the KGB couldn't have found elsewhere.

Kouzminov claimed in his book that the KGB targeted "secret" experiments at USAMRIID. But Peters said that almost all the lab's work was published in scholarly journals, and scientists there worked on only two classified projects during that era. In one, scientists screened blood serum from U.S. Special Forces for novel infections. In another, the lab analyzed blood from two elite Soviet commandos.

Still, the Soviets were deeply suspicious of Detrick. Many former Russian bioweapons experts remain so.

Dr. Pyotr Burgasov, a former chief sanitary physician of the Soviet Union, recalled in a 2002 interview with The Sun how he was escorted through Fort Detrick in the late 1960s - and was barred from one building. Detrick officials told him they feared he might contaminate the sterile research animals inside. But 11 years after the U.S.S.R. crumbled, he still didn't buy that explanation. "I am told America shows its research to scientists," he said. "But they showed nothing to me."

Distrust evidently bred cynicism. According to defectors, at the moment Soviet leaders signed the Biological Weapons Convention in 1975, they were pursuing a large-scale clandestine germ weapons program. After the deception was exposed, President Boris N. Yeltsin ordered a halt to offensive research in 1992.

Kouzminov, in a series of e-mails, defended his book against critics, saying that his aim was to raise an alarm about the "possibility" that several nations - including the U.S. - are conducting offensive bioweapons research. He also proposes the creation of an International Biological Security Agency, modeled on the International Atomic Energy Agency, to prevent proliferation.

Russia's biodefense establishment might have a vested interest in raising fears about U.S. intentions, some experts think. If Russia's leaders feel threatened, one said, they could increase spending on biodefense and intelligence agencies - institutions that have struggled for money since the end of the Cold War.

The FBI also questions whether Biological Espionage has an ulterior purpose. Agency spokesman William D. Carter said in a statement that "there is no way to discount that this book (like other books by former intel officers who seem to have no problem moving around, including into and out of Russia) is not part of a disinformation campaign by the Russians."

Kouzminov, who left Russia with his family in 1994, called the FBI's disinformation comment "rubbish," a reflection of Cold War thinking. "I have written this book purely from my heart," he wrote. "I was alone in this, without any group ... behind my back."

U.S. Biodefense Lab Raises Concerns

UPI

FORT DETRICK, Md. (UPI) -- The Bush administration is building a massive biodefense laboratory in Maryland that will simulate calamitous bioterrorism attacks, it was reported Sunday.

But much of what the National Biodefense Analysis and Countermeasures Center in Fort Detrick, Md., does may never be publicly known because the White House intends to operate the facility largely in secret, the Washington Post reported.

In an unusual arrangement, the building itself will be classified as "highly restricted space," from the reception desk to the lab benches to the cages where animals are kept, the newspaper said.

Not even nuclear labs operate with such secrecy.

The covertness has some arms-control specialists concerned that U.S. biodefense policy, as carried out by the Department of Homeland Security, the center's creator, could "skirt the edges" of an international treaty outlawing the production of even small amounts of biological weapons, the newspaper said.

The administration insists the center's work is purely defensive and thus fully legal. It has rejected calls for oversight by independent observers outside the department's network of government scientists and contractors.

July 26, 2006

Post-Vaccine Treatment Funding Uncertain Again

By David RuppeGlobal Security Newswire

WASHINGTON — Funding for U.S. military clinics that investigate and treat illnesses following vaccinations for anthrax, smallpox and other diseases is in doubt for next fiscal year, once again placing their continued operation in jeopardy (see GSN, Jan. 10).

The Bush administration for fiscal 2007 did not request any funding for the Vaccine Healthcare Centers, which are estimated to cost $6 million annually to operate.

The Senate Appropriations Committee last week approved $2 million for the centers, which would be provided in addition to anything the military services might contribute from their health budgets, according to the committee’s report for its fiscal 2007 defense appropriations bill. No such funding was included in the House version of the bill approved June 20.

The centers are headquartered at the Army’s Walter Reed Army Medical Center, and also located at the Naval Medical Center in Portsmouth, Va., the Womack Army Medical Center at Fort Bragg, N.C., and the Air Force’s Wilford Hall Medical Center in San Antonio, Texas.

Congress created the first center at Walter Reed in 2000, as a site for specialized assessment, treatment and study of military and civilian personnel reportedly sickened by then-mandatory anthrax vaccinations. The other three sites opened in 2004.

Since their creation, the Army has reluctantly paid for the Navy and Air Force centers, with the Army Medical Command shifting money from its budget to keep all the sites going. Congress authorized $3 million for the centers for this fiscal year.

In apparent anticipation of the Iraq invasion, the Bush administration in 2002 began mandatory anthrax vaccinations for more than 1 million U.S. military personnel. Mandatory inoculations stopped after a federal judge ruled in October 2004 that they could not be required because the Food and Drug Administration did not properly approve the vaccine for the intended use.

The Food and Drug Administration reapproved the vaccine in December 2005, declaring it “safe and effective.” The military has not yet, though, said it would resume mandatory anthrax vaccinations. It is allowed to administer the vaccine on a strictly voluntary basis.

From fiscal 2003 and fiscal 2004, the centers treated approximately 1,200 recipients of the anthrax and other vaccines presenting a range of side effects, from muscle pain and chronic fatigue to multiple sclerosis, according to figures provided to Global Security Newswire by the Army (see GSN, May 6, 2005).

GSK bird flu vaccine is the 'best so far'

Scotsman News

PHARMACEUTICAL giant GlaxoSmithKline claims to have created the most effective vaccine so far against the deadly H5N1 strain of bird flu.

GlaxoSmithKline (GSK) says its vaccine produces the highest reported immune response at a low dosage because of a special "adjuvant" - an ingredient which stimulates the immune system and boosts the body's response to the vaccine.

The vaccine - which has not yet been peer-reviewed - could be used in lower doses, making it cheaper to produce, it was reported today.

GSK chief executive JP Garnier hailed it as "a big breakthrough" and said the company could produce hundreds of millions of doses by Christmas.

No final decisions have been made about cost, but it could be as little as £4 a dose.

Earlier this month Spain reported the discovery of its first case of H5N1 in a wild bird.

Mr Garnier said: "We have used this special adjuvant and now we are able to demonstrate very significant and totally satisfactory efficacy and safety with a dose that is only 3.8 microgrammes.

"The meaning of this is that we are going to be in a position, starting later this year, to produce hundreds of millions of doses of an effective pandemic vaccine, so this is a big breakthrough."

July 25, 2006

Bio-terror jabs 'too dangerous'

Mass vaccination would not be needed to contain a smallpox outbreak started by bioterrorists in Britain and could cost more lives than it saved, according to research.

A study, published in the journal Proceedings of the National Academy of Sciences, indicated that an attack could be brought under control using quarantine and targeted inoculation.

While the Government has ordered a stockpile of smallpox vaccine, it is highly unlikely that all or even most of it would be needed in the event of an attack, says the study by Professor Neil Ferguson of Imperial College, London, and Steven Riley of the University of Hong Kong.

As the vaccine causes serious side-effects in 1 in 1,000 people and would kill an estimated 1 in 35,000, widespread inoculation would almost certainly result in more deaths than lives saved.

The only scenario in which mass vaccination would be justified would be an attack abroad which led to smallpox becoming endemic in a country such as the US.

This would lead to a steady trickle of infected people travelling to Britain, making containment by quarantine and targeted jabs harder to achieve.

Radiation may offer better way to make vaccines

“Vaccines often protect mice but not people so the idea must be tested more,”....

WASHINGTON (Reuters) - Vaccines made with bacteria killed by gamma rays may be more effective than those made using standard heat or chemical inactivation, U.S. government researchers said on Wednesday.

Such vaccines do not have to be kept cold, the team at the University of California, San Diego, School of Medicine reported in the journal Immunity.

Dr. Sandip Datta and colleagues made a vaccine from Listeria monocytogenes bacteria, a common cause of food poisoning.

The Listeria were killed with gamma rays and the vaccine protected mice infected with live Listeria, unlike vaccines made with heat-killed bacteria.

"This advance is potentially of great importance in meeting the challenge of creating vaccines that are safe, effective and simple to manufacture and transport," said Dr. Elias Zerhouni, head of the National Institutes of Health, which paid for the study.

"Although completely inactivated by the radiation, and thus unable to cause illness, irradiated bacterial pathogens evidently retain characteristics that prompt the immune system to mount a full-fledged defense," Datta said in a statement.

Vaccines can be made in three ways -- using an attenuated, or weakened, form of live bacteria or virus, using a killed germ, or using pieces of DNA from a bacteria or virus.

Most attenuated vaccines must be kept cold, but the UCSD researchers found that mice could be protected by vaccination with irradiated Listeria that had been freeze-dried into a powder.

This might mean that such vaccines could be used in hot places without electricity, the researchers said.

Vaccines often protect mice but not people so the idea must be tested more, the researchers noted.

July 24, 2006

Bird flu spiraling out of control in Indonesia

(NewsTarget) While Indonesia discovered its first bird flu outbreak fairly late in comparison to some other infected countries, it has endured one of the fastest spreads, with 42 human H5N1-caused fatalities reported since the first case was confirmed a year ago.

Until the latest Indonesian death was confirmed yesterday, Vietnam topped Indonesia as the country hardest hit by bird flu with 42 deaths since 2003 -- but Vietnam has not had a single human case this year. The disease continues to rage out of control in Indonesia, and experts say it will only get worse.

“It’s like trying to fix the roof while there’s a storm going on,” said Dick Thompson, a spokesman for the World Health Organization. “Until the animal situation gets under control, there’s going to be this steady drip, drip, drip of human cases, and that’s a problem.”

Although H5N1 is still a relatively rare disease among Indonesia's 245-million-strong population --compared to Vietnam's 84 million people -- experts say the country's decentralized government is exacerbating the problem. Since the fall of the Suharto dictatorship in 1998, most regions of the country have moved to a system of self-government; a condition most prefer to the harsh central control of the previous government in Jakarta.

“Decentralized units get very wary when the center takes on emergency powers,” said Dr. David Nabarro, chief pandemic flu coordinator for the United Nations.

The lack of communication and cooperation between the regions has assisted bird flu's spread. Commonly, the response to a bird flu outbreak in Indonesia consists of limited culling and a vaccination ring around the cull, a practice that has been largely ineffective compared to the repression methods in other infected countries. Thailand quickly stemmed the tide of their outbreak by culling millions of chickens, and Vietnam brought their infections under control with mandatory vaccinations.

Other issues assisting the disease's spread are the sheer prevalence of poultry in Indonesia, a lack of compensation for culled birds -- causing a lack of cooperation from farmers -- and even superstition. Members of one village refused vaccination for the infection because they believed it had been brought on by witchcraft.

Indonesia does have the potential to fight off bird flu, as it did when a polio outbreak hit last year. A lone case of the disease was reported in May of 2005, which quickly grew to 303 cases, but a countrywide immunization campaign reduced the cases to just two so far this year. But so far, the country has shown no signs of such organization against bird flu.

July 22, 2006

Scientific Integrity Under A Microscope - FDA scientists reported interference with their scientific work

http://www.centredaily.com/mld/centredaily/news/opinion/15096667.htm

Below are excerpts from a survey of U.S. Food and Drug Administration scientists by two advocacy groups. Released on Thursday, the survey results are at www.ucsusa.org.

The Union of Concerned Scientists and Public Employees for Environmental Responsibility distributed a 38-question survey to scientists at the FDA to obtain their perceptions about scientific integrity in the agency. Nearly 1,000 scientists filled out and returned the survey.

a.. Large numbers of FDA scientists reported interference with their scientific work. Almost one in five responded, "I have been asked, for nonscientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document." More than three in five knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions." Three in five also knew ofcases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions."

b.. Responses suggest that the agency's ability to fulfill its mission -- protecting public health -- is being put at risk. Only half feel the "FDA is acting effectively to protect public health." Nearly half think that the "FDA routinely provides complete and accurate information to the public."

c.. Scientists report being afraid to speak frankly about safety concerns and feel constrained in their roles as scientists. One-fifth say they "have been asked explicitly by FDA decisionmakers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials."

d.. FDA scientists reported that they have inadequate resources to perform even the basic work of the agency. Nearly 70 percent do not believe the FDA has sufficient resources to effectively perform its mission. Less than half say they " respect the integrity and professionalism of FDA leadership." Less than a third think the agency "is moving in the right direction."

e.. Scientists had strong opinions about reforms that would address some of their concerns. Nearly two in three said that the "laws and regulations that govern FDA, including the agency's structure, need change for the agency to better serve the public." More than four in five agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened." Scientists also responded to the open question, "The integrity of the scientific work produced by FDA could best be improved by . . ." Answers included:

a.. "Removing politics from the review process and making decisions based solely on science.b.. "Make culture regarding saying `no' or giving negative results more acceptable --it's very difficult now with meetings, etc. Management is VERY pharma-friendly."c.. "Post-approval long-term monitoring of clinical trials."

July 20, 2006

Gates Foundation to Finance Search for H.I.V. Vaccine

SEATTLE, July 19 — The Bill and Melinda Gates Foundation awarded more than a quarter of a billion dollars today to researchers in 19 countries to speed the lagging development of an H.I.V. vaccine.

The grants are the largest private investment in making such a vaccine, the foundation said. They represent a significant shift in emphasis, to large-scale collaborative projects instead of small teams of researchers working independently.

The money will be given over five years to 16 scientific teams, including two New York groups. The scientists applied for the grants before Warren E. Buffett announced last month that he was giving $31 billion to the Gates Foundation.

The Gates Foundation has made development of an effective vaccine against H.I.V., the virus that causes AIDS, a major goal, and the new grants bring to $528 million the foundation’s investment for this purpose. By contrast, the National Institutes of Health has spent $3.4 billion since the 1980’s to develop a vaccine.

A vaccine to fight H.I.V., the human immunodeficiency virus, is the best hope to control the AIDS epidemic, health officials and experts say. But that hope had been frustrated again and again.

In 1984, Margaret M. Heckler, President Ronald Reagan’s health and human services secretary, and Dr. Robert Gallo, a discoverer of the virus, predicted an H.I.V. vaccine by 1986.

Although more than 30 experimental H.I.V. vaccines have been tested in people, only one has completed full-scale testing. That vaccine, Aidsvax, made by VaxGen, failed in a large trial that ended in 2003.

Until now, most H.I.V. vaccine research has been conducted by small independent teams. But the new grants are being structured to encourage the 165 scientists receiving them to join forces. The goal is to overcome major immunologic and other scientific hurdles that hinder development of such a vaccine.

The body can invoke two types of immune reactions to defend against dangerous infectious agents.

One way is to produce neutralizing antibodies, which are proteins that bind like a lock and key to areas on the infectious agent.

A second way, cellular immunity, is to produce T-cells that seek and destroy infected cells.

Most licensed vaccines work by stimulating the body to make neutralizing antibodies. But experimental H.I.V. vaccines have failed to produce such antibodies. The virus’s propensity to mutate and produce different genetic subtypes will require an effective vaccine to produce antibodies that can neutralize a wide range of strains.

The foundation said an effective vaccine might also have to stimulate T-cell production. Six grants will focus on ways to develop cellular immunity.

Five grants will go toward identifying new techniques to develop novel vaccines that produce neutralizing antibodies.

The remaining five grants are for creating central laboratories and information analysis facilities so that all the grant recipients can openly share data and develop standardized ways to compare their findings. Lack of such standardized tools hampers H.I.V. vaccine research, the foundation said.

A team led by Susan Zolla-Pazner, an immunologist at New York University, will receive $8.4 million to investigate the use of a specific area of the outer coat of the virus, known as the V3 region. The aim will be to develop neutralizing antibodies that attack a broad range of H.I.V. strains.

Another team led by Dr. David Ho of the Aaron Diamond AIDS Research Center in Manhattan will receive $24.7 million to design experimental H.I.V. vaccines that bind to dendritic cells. These immune cells help strengthen production of antibodies and cellular immunity.

July 19, 2006

Lawmaker Alleges FDA, Merck Collaborated

Associated PressBy ANDREW BRIDGES

A federal health official worked with drug maker Merck to discredit a governmentwhistleblower who publicized safety risks associated with the painkiller Vioxx, a lawmaker alleged Wednesday in seeking an investigation.

Sen. Charles Grassley, R-Iowa, asked the inspector general at the Health and Human Services Department to probe whether the Food and Drug Administration and Merck acted in concert to call into question the safety findings made by Dr. David Graham, an FDA drug safety official.

In a letter Wednesday, Grassley cited handwritten notes made by the Merck employee documenting an Oct. 13, 2004, conversation with the FDA official that suggests the two collaborated.

The FDA official mentioned an "opportunity to get (the) message out" on Graham, a longtime employee of the agency, and provide journalists with a company critique of him, according to notes quoted in the letter.

"It is no secret that Dr. Graham was and is a critic of the FDA. However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees," Grassley said in the letter to Inspector General Daniel Levinson. The FDA, Grassley said, must maintain a "clear, bright line between the regulated and the regulator."

FDA spokeswoman Susan Bro had no comment.

Merck & Co. Inc. said in a statement that it has the "right to express our views when we believe information others have presented is not fair and balanced. Dr. Graham's conclusions with regard to Vioxx differed from those of the FDA and to that extent, the FDA and Merck separately expressed their scientific views to the public and scientific community."

Merck announced the voluntary withdrawal of Vioxx in September 2004, citing a study that showed the pain medication could double risk of heart attack or stroke if taken for 18 months or longer.

Two months later, Graham testified before a Senate committee that the FDA had fumbled its handling of Vioxx, and mishandled safety problems with five other widely used drugs. The FDA defended its oversight of Vioxx before the hearing; an agency official later dismissed Graham's research as "junk science."

The following month, 22 members of Congress signed a letter asking the FDA to investigate the "smear campaign" against him.

Merck now faces more than 16,000 Vioxx-related lawsuits.

The meeting cited by Grassley was held two weeks after the drug was withdrawn.

FDA e-mails seen by The Associated Press indicate that the agency shared in advance with Merck details about a presentation that Graham was to make in France in August 2004 about the dangers of Vioxx. The e-mails suggested that such a practice was commonplace.

Merck then issued a statement saying it stood by the safety of Vioxx. An FDA spokeswoman at the time said removing the drug was "not on the table."

The notes excerpted by Grassley indicate the FDA later went even further in helping Merck rebut Graham's work.

The FDA's Dr. Brian Harvey suggested to Merck's Dr. Ned Braunstein "an official rebuttal on Graham," according to the notes, which were admitted as evidence ina federal Vioxx trial.

Graham said he was "quite shocked" to learn about Braunstein's notes.

"This actually demonstrates more clearly just how widespread the organized campaign to discredit and smear me was," according to a transcript of a sworn deposition that Graham gave May 9, 2006.

Attorneys for Merck have sought to keep portions of the deposition from jurors, saying they go beyond anything Graham has said previously. The deposition was seen by the AP.

July 18, 2006

Tests link to Gulf War symptoms

The UK Times By Michael Evans

Servicemen who took part in the Porton Down chemical warfare experiments from 1939 to 1989 suffered from the same health problems as thousands of veterans of the 1991 Gulf War, an official study has discovered.

The five most prevalent symptoms, shared by both groups, were headaches, outbursts of anger, fatigue, feeling unrefreshed after sleep, and sleeping difficulties.

The similarity in health problems was uncovered by independent researchers at Oxford University who have been studying the long-term effects of the Porton Down experiments. The study is being co-ordinated by the Medical Research Council and funded by the Ministry of Defence.

Gulf War veterans complaining of ill health have blamed the vaccines they received to counter the threat of chemical and biological warfare. The preliminary findings on the Porton Down tests, published on the website of the journal, Occupational Medicine, said the symptoms among the volunteers became apparent within the first five years after they had taken part in the experiments.

'Flurry' of anthrax cases ver weekend

Quote: "The man, who is not being identified, is being treated with antibiotics and is expected to make a full recovery."

Officials were optimistic the anthrax outbreak in northeast Saskatchewan had turned a corner late last week, but over the weekend a flurry of new cases has deflated that good feeling.

Dr. Sandra Stephens, a program specialist with the animal health program network of the Canadian Food Inspection Agency said 13 more positive premises over the weekend brings the number of quarantine sites up to 45, of which 39 are confirmed positive."We are all hoping to turn a corner but because of the environmental conditions we had in the entire area this spring there is always a risk because we don't know where the anthrax spores are buried," she said yesterday, Monday.

Ross Hawkes, a student veterinarian with the Mohawk Animal Clinic in Melfort is out collecting samples of the dead animals for submission to laboratories.

He said new cases have been popping up all over the area.

"We have some suspect cases we are still waiting for confirmation on. There have been some cases we have taken samples from that have been highly suspect and we are just waiting for word," he said late last week.

On the 45 quarantined sites Stephens said the animal death toll has climbed to 162 and those cases were in five new rural municipalities.

Joining the list of previous RMs is the RM of Ponass Lake (367), Pleasantdale (398) Humboldt (370), Nipawin (487) and Torch River (488).

As if the growth of the anthrax outbreak, which started on June 26, wasn't enough, a man in Melfort has been confirmed to have contracted skin anthrax.

Dr. Ross Findlater, Saskatchewan's chief medical health officer said the man, a 50-year-old farmer from the Melfort area is being treated for skin anthrax.

"That person did have direct skin to skin contact, unprotected with a dead animal and also he had a cut as well so there are a lot of risk factors as opposed to somebody just walking down the street in Melfort," Findlater said.

The man, who is not being identified, is being treated with antibiotics and is expected to make a full recovery.

In the wake of the human case Findlater said there are two main messages for the people of Melfort. He said people should not worry too much about it as it is not a big public health threat and cannot be spread from person to person.

"But if you are on a farm where there is infected cattle and you get a skin lesion it is important you get it checked out. If it does turn out to be anthrax, it is easily treatable."

The good news in the battle against the outbreak is after nearly a week of waiting a large shipment of vaccine has been delivered to the local veterinary clinics.

Hawkes said there were about 11,000 doses expected to arrive at the Mohawk Animal Clinic late last week straight from the manufacturer.

Although Hawkes is relieved the shipment has arrived he said the producers are happier than he is.

"It has been frustrating for them and for us not being able to get it quick enough because they could have vaccinated their cows a week ago," he said.

"We are hoping not to see too many more positive cases after we get all this vaccine distributed."